Generation of Immunological Reagents 100%
Preclinical Evaluations 90%
Validated Test Protocols 80%
GLP Compliant Toxicology Report - in progress 0%
Delivery to Regulatory Authority and Ethical Review of Protocol - in progress 0%
Sufficient Vaccine Grade Material Ready to Use 100%
Initiate Recruitment of First Volunteer Group - in progress 0%
Initiate Recruitment of Second Volunteer Group 0%
Report on Full Immune Responses and Immunological Memory 0%
End of Study Report 0%
The CDVAX consortium is pleased to announce a number of scientific presentations that will be made in the first half of 2016. The R&D programme will be presented during the BioEurope Spring meeting in Stockholm on the 4-6th April 2016. There will also be multiple presentations of different aspects of the FP7 collaboration during the 7th European Spores Conference in London on the 18- 20th April 2016.
Based on feedback from the German national regulatory authority (PEI), the CDVAX consortium is pleased to announce the start of formal GLP-compliant toxicology experiments to characterise both the safety and immunogenicity of the CDVAX spore following repeated oral administration.
The CDVAX consortium is pleased to announce the successful completion of the first GMP batch of the CDVAX product that will be used for clinical evaluation of the consortium’s C. difficle vaccine. Dr Annie Van Broekhoven, CEO of Q-Biologicals and the consortium member responsible for production aspects, commented that “it is a great achievement for both the CDVAX consortium and Q-Biologicals to have successfully manufactured this GMP spore vaccine batch which will be used for the clinical studies”.
Following discussions and formal scientific advice from the German national regulatory authority (Paul-Ehrlich Institute; PEI), the CDVAX consortium has obtained validation of its the preclinical and clinical development strategy in readiness to launch the first-in-man study. A technical batch of CDVAX product is already available and the GLP-compliant toxicology studies and GMP production of the CDVAX will be launched imminently.